Mumbai: The Pune-based Serum Institute of India (SII), which Prime Minister Narendra Modi visited last Saturday to acquaint himself with the vaccine development to combat the Covid-19 pandemic, will file an Rs.100 crore defamation case against a volunteer who publicly claimed to have developed side-effects during the course of trials.
Responding to what it calls “malicious and misconceived” allegations, SII has said it will file an Rs. 100 crore defamation suit against a Covishield vaccine trial participant for claiming that he had to suffer a “virtual neurological breakdown” after being administered a dose.
The SII, the world’s largest vaccine manufacturer, said while it sympathized with the volunteer’s medical condition there was “absolutely no correlation with the vaccine trial and the medical condition of the volunteer”.
“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation between the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial.”
“The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company,” the statement added.
A 40-year-old Chennai man, who volunteered for the third phase of the Covid vaccine trial conducted by the SII, has claimed Rs. 5 crores as compensation for “a serious adverse event after being administered the under-trial vaccine”.
He was administered the dose at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER) on October 1.
According to his legal notice, filed on November 21, ten days later he began experiencing “severe headaches”, “total behavioral change” and “irritation towards light and sound”. Subsequently, the notice claims, he could not recognize or speak to anyone.
On October 26 he was discharged from hospital after suffering from “Acute Encephalopathy” that, the notice claims, was “an extreme side effect of the test vaccine…”
The Drugs Controller General of India (DCGI) and an ethics committee at the Sri Ramachandra Institute will investigate the man’s claim, media reports said.
The Covishield vaccine is among the more promising candidates in later stages of testing around the world. On Saturday evening SII CEO Adar Poonawalla, after meeting the Prime Minister, said the company would apply for an emergency use license for Covishield.
At least 100 million doses would be available by January 2021, and hundreds of million by the end of February, he added.
(VP)